Devices and methods for the delivery of molecular sieve materials for the formation of blood clots

ABSTRACT

An apparatus for promoting the clotting of blood and controlling bleeding comprises a receptacle for retaining molecular sieve material in particulate form therein. A pad for controlling bleeding comprises a mesh structure and a rigid or semi-rigid support attached to the mesh structure to facilitate the application of pressure to the pad and the wound. A bandage applicable to a bleeding wound comprises a mesh structure and a flexible substrate attached to the mesh structure, the substrate being a cloth or plastic member that may be adhesively attached to cover a wound. In any embodiment, at least a portion of the receptacle or mesh structure is defined by a mesh having openings therein, and at least a portion of the particulate molecular sieve material is in direct contact with blood.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/555,876, entitled “Devices and methods for the delivery of molecularsieve materials for the formation of blood clots,” filed Sep. 9, 2009,which is continuation of U.S. patent application Ser. No. 11/054,918,entitled “Devices and methods for the delivery of molecular sievematerials for the formation of blood clots,” filed Feb. 9, 2005. Thecontents of all the above-referenced applications are incorporatedherein by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to blood clotting devices and,more particularly, to blood clotting materials, devices incorporatingsuch materials, and methods for the delivery of such materials for useas bleeding control devices.

2. Description of the Related Art

Blood is a liquid tissue that includes red cells, white cells,corpuscles, and platelets dispersed in a liquid phase. The liquid phaseis plasma, which includes acids, lipids, solublized electrolytes, andproteins. The proteins are suspended in the liquid phase and can beseparated out of the liquid phase by any of a variety of methods such asfiltration, centrifugation, electrophoresis, and immunochemicaltechniques. One particular protein suspended in the liquid phase isfibrinogen. When bleeding occurs, the fibrinogen reacts with water andthrombin (an enzyme) to form fibrin, which is insoluble in blood andpolymerizes to form clots.

In a wide variety of circumstances, animals, including humans, can bewounded. Often bleeding is associated with such wounds. In somecircumstances, the wound and the bleeding are minor, and normal bloodclotting functions in addition to the application of simple first aidare all that is required. Unfortunately, however, in other circumstancessubstantial bleeding can occur. These situations usually requirespecialized equipment and materials as well as personnel trained toadminister appropriate aid. If such aid is not readily available,excessive blood loss can occur. When bleeding is severe, sometimes theimmediate availability of equipment and trained personnel is stillinsufficient to stanch the flow of blood in a timely manner.

Moreover, severe wounds can often be inflicted in remote areas or insituations, such as on a battlefield, where adequate medical assistanceis not immediately available. In these instances, it is important tostop bleeding, even in less severe wounds, long enough to allow theinjured person or animal to receive medical attention.

In an effort to address the above-described problems, materials havebeen developed for controlling excessive bleeding in situations whereconventional aid is unavailable or less than optimally effective.Although these materials have been shown to be somewhat successful, theyare sometimes not effective enough for traumatic wounds and tend to beexpensive. Furthermore, these materials are sometimes ineffective insome situations and can be difficult to apply as well as remove from awound.

Additionally, or alternatively, the previously developed materials canproduce undesirable side effects. For example, prior art blood clottingmaterial is generally a powder or a fine particulate in which thesurface area of the material often produces an exothermic reaction uponthe application of the material to blood. Oftentimes excess material isunnecessarily poured onto a wound, which can exacerbate the exothermiceffects. Depending upon the specific attributes of the material, theresulting exothermia may be sufficient to cause discomfort to or evenburn the patient. Although some prior art patents specifically recitethe resulting exothermia as being a desirable feature that can provideclotting effects to the wound that are similar to cauterization, thereexists the possibility that the tissue at and around the wound site maybe undesirably impacted.

Furthermore, to remove such materials from wounds, irrigation of thewound is often required. If an amount of material is administered thatcauses discomfort or burning, the wound may require immediate flushing.In instances where a wounded person or animal has not yet beentransported to a facility capable of providing the needed irrigation,undesirable effects or over-treatment of the wound may result.

Bleeding can also be a problem during surgical procedures. Apart fromsuturing or stapling an incision or internally bleeding area, bleedingis often controlled using a sponge or other material used to exertpressure against the bleed site and/or absorb the blood. However, whenthe bleeding becomes excessive, these measures may not be sufficient tostop the flow of blood. Moreover, any highly exothermic bleed-controlmaterial may damage the tissue surrounding the bleed site and may not beconfigured for easy removal after use.

Based on the foregoing, it is a general object of the present inventionto provide devices for controlling bleeding and methods of their usethat overcome or improve upon the prior art.

SUMMARY OF THE INVENTION

According to one aspect, the present invention resides in an apparatusfor promoting the clotting of blood, thereby controlling bleeding. Theapparatus comprises a receptacle for retaining molecular sieve materialin particulate form therein. At least a portion of the receptacle isdefined by a mesh having openings therein such that when the apparatusis applied to a bleed site, the particulate molecular sieve materialcomes into contact with blood through the openings.

Other aspects of the present invention include a pad for controllingbleeding and a bandage applicable to a bleeding wound. In both the padand the bandage, there is a mesh structure and particles of molecularsieve material retained therein. In the pad embodiment, there is a rigidor semi-rigid support attached to the mesh structure to facilitate theapplication of pressure to the pad and the wound. In the bandage, thereis a flexible substrate attached to the mesh structure, the substratebeing a cloth or plastic member that may be adhesively attached to covera wound. In any embodiment, the mesh structure may be defined by aplurality of members (strands, filaments, or strips of synthetic ornatural material) interconnected and arranged to define openings. Theopenings are sized to allow contact to be maintained between theparticles of the molecular sieve material and blood.

In yet another aspect of the present invention, a method of dressing ableeding wound includes providing a molecular sieve material in particleform and retaining the material in a mesh structure, placing the meshstructure on a bleeding wound such that the molecular sieve materialcomes into contact with blood flowing from the wound, applying pressureto the mesh structure to ensure contact of the material with the blood,and removing the mesh structure from the wound.

An advantage of the present invention is that upon completion of theapplication of any of the devices of the present invention to a bleedingwound, the devices can be easily removed. In particular, because thezeolite material is in granule, bead, or pellet form and encased in apouch or mesh structure, the material can be cleanly pulled away fromthe treated wound and disposed of. Accordingly, little or no irrigationof the wound is required to flush away remaining zeolite. In devices inwhich the pouch containing zeolite material is incorporated into anadhesive bandage, the device can be left on the wound for the amount oftime necessary to cause clotting.

Another advantage is that the particlized form of the zeolite materialallows the material to react less exothermically with blood. As theparticle size increases (e.g., from fine to coarse), the surface area ofthe particles that the blood can come into contact with decreases. Theporous nature of the material still allows liquid blood constituents tobe wicked away to cause thickening of the blood, thereby facilitatingthe formation of clots. Because the particle surface area exposed to theblood is reduced, a less aggressive drawing of moisture from the bloodis realized, which thereby tempers the exothermic effects experienced atthe wound site.

Still another advantage of the present invention is that the proper doseof molecular sieve material can be readily applied to an open wound.Particularly when the device is a porous pouch containing zeolitematerial, the device can be readily removed from sterilized packagingand held directly at the points from which blood emanates to facilitateclotting of the blood without spilling powder or pellets outside thewound area. Guesswork, estimation, or calculation of the amounts ofmolecular sieve material for application to a bleeding wound iseliminated. Accordingly, little or no molecular sieve material iswasted.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic representation of a blood clotting device of thepresent invention.

FIG. 2 is a side view of the blood clotting device of FIG. 1illustrating the retaining of molecular sieve particles in a meshcontainer.

FIG. 3 is a side view of a pressure pad incorporating the molecularsieve particles encapsulated in a mesh container for pressureapplication to a bleeding wound.

FIG. 4 is a perspective view of a bandage incorporating the molecularsieve particles in a mesh container for application to a bleeding wound.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Disclosed herein are devices and methods for delivering materials towounds to promote the clotting of blood and the dressing of the wounds.The devices generally comprise expedients or apparatuses that can beapplied to bleeding wounds such that the materials contact the tissue ofthe wound to minimize or stop a flow of blood by absorbing at leastportions of the liquid phases of the blood, thereby promoting clotting.One apparatus comprises a receptacle for retaining molecular sievematerial in particulate form therein. At least a portion of thereceptacle is defined by a mesh having openings therein, and at least aportion of the particulate molecular sieve material is in direct contactwith blood through the openings.

The molecular sieve material used in the present invention may be asynthetic polymer gel, cellulosic material, porous silica gel, porousglass, alumina, hydroxyapatite, calcium silicate, zirconia, zeolite, orthe like. Exemplary synthetic polymers include, but are not limited to,stylene-divinylbenzene copolymer, cross-linked polyvinyl alcohol,cross-linked polyacrylate, cross-linked vinyl ether-maleic anhydridecopolymer, cross-linked stylene-maleic anhydride copolymer orcross-linked polyamide, and combinations thereof.

The molecular sieve material is preferably a zeolite. Other molecularsieve materials that may be used include, but are not limited to,faujasite. As used herein, the term “zeolite” refers to a crystallineform of aluminosilicate having the ability to be dehydrated withoutexperiencing significant changes in the crystalline structure. Thezeolite may include one or more ionic species such as, for example,calcium and sodium moieties. Typically, the zeolite is a friablematerial that is about 90% by weight calcium and about 10% by weightsodium. The calcium portion contains crystals that are about 5 angstromsin size, and the sodium portion contains crystals that are about 4angstroms in size. The preferred molecular structure of the zeolite isan “A-type” crystal, namely, one having a cubic crystalline structurethat defines round or substantially round openings.

The zeolite may be mixed with or otherwise used in conjunction withother materials having the ability to be dehydrated without significantchanges in crystalline structure. Such materials include, but are notlimited to, magnesium sulfate, sodium metaphosphate, calcium chloride,dextrin, a polysaccharide, combinations of the foregoing materials, andhydrates of the foregoing materials.

Zeolites for use in the disclosed applications may be naturallyoccurring or synthetically produced. Numerous varieties of naturallyoccurring zeolites are found as deposits in sedimentary environments aswell as in other places. Naturally occurring zeolites that may beapplicable to the compositions described herein include, but are notlimited to, analcite, chabazite, heulandite, natrolite, stilbite, andthomosonite. Synthetically produced zeolites that may also find use inthe compositions and methods described herein are generally produced byprocesses in which rare earth oxides are substituted by silicates,alumina, or alumina in combination with alkali or alkaline earth metaloxides.

Various materials may be mixed with, associated with, or incorporatedinto the zeolites to maintain an antiseptic environment at the woundsite or to provide functions that are supplemental to the clottingfunctions of the zeolites. Exemplary materials that can be used include,but are not limited to, pharmaceutically-active compositions such asantibiotics, antifungal agents, antimicrobial agents, anti-inflammatoryagents, analgesics (e.g., cimetidine, chloropheniramine maleate,diphenhydramine hydrochloride, and promethazine hydrochloride),bacteriostatics, compounds containing silver ions, and the like. Othermaterials that can be incorporated to provide additional hemostaticfunctions include ascorbic acid, tranexamic acid, rutin, and thrombin.Botanical agents having desirable effects on the wound site may also beadded.

In one embodiment of the present invention, a device for facilitatingthe clotting of blood directly at a wound site is shown with referenceto FIG. 1. The device is a permeable pouch that allows liquid to enterto contact blood clotting zeolite (or other molecular sieve) materialretained therein. Sealed packaging (not shown) provides a sterileenvironment for storing the device until it can be used. The device,which is shown generally at 10 and is hereinafter referred to as “pouch10,” comprises a screen or mesh 12 and zeolite particles 14 retainedtherein by the screen or mesh. The mesh 12 is closed on all sides anddefines openings that are capable of retaining the zeolite particles 14therein while allowing liquid to flow through. As illustrated, the mesh12 is shown as being flattened out, and only a few zeolite particles 14are shown.

The zeolite particles 14 are substantially spherical or irregular inshape (e.g., balls, beads, pellets, or the like) and about 0.2millimeters (mm) to about 10 mm in diameter, preferably about 1 mm toabout 7 mm in diameter, and more preferably about 2 mm to about 5 mm indiameter. In any embodiment (balls, beads, pellets, etc.), less particlesurface area is available to be contacted by blood as the particle sizeis increased. Therefore, the rate of clotting can be controlled byvarying the particle size. Furthermore, the adsorption of moisture(which also has an effect on the exothermic effects of the zeolite) canalso be controlled.

The mesh 12 is defined by interconnected strands, filaments, or stripsof material. The strands, filaments, or strips can be interconnected inany one or a combination of manners including, but not limited to, beingwoven into a gauze, intertwined, integrally-formed, and the like.Preferably, the interconnection is such that the mesh can flex whilesubstantially maintaining the dimensions of the openings definedthereby. The material from which the strands, filaments or strips arefabricated may be a polymer (e.g., nylon, polyethylene, polypropylene,polyester, or the like), metal, fiberglass, or an organic substance(e.g., cotton, wool, silk, or the like).

Referring now to FIG. 2, the openings defined by the mesh 12 aredimensioned to retain the zeolite particles 14 but to accommodate theflow of blood therethrough. Because the mesh 12 may be pulled tightaround the zeolite particles 14, the particles may extend through theopenings by a distance d. If the zeolite particles 14 extend through theopenings, the particles are able to directly contact tissue to which thepouch 10 is applied. Thus, blood emanating from the tissue immediatelycontacts the zeolite particles 14, and the water phase thereof is wickedinto the zeolite material, thereby facilitating the clotting of theblood. However, it is not a requirement of the present invention thatthe zeolite particles protrude through the mesh.

To apply the pouch 10 to a bleeding wound, the pouch is removed from thepackaging and placed on the bleeding wound. The zeolite particles 14 inthe mesh 12 contact the tissue of the wound and/or the blood, and atleast a portion of the liquid phase of the blood is adsorbed by thezeolite material, thereby promoting the clotting of the blood.

Another embodiment of the present invention is a pad which is shown at20 with reference to FIG. 3 and is hereinafter referred to as “pad 20.”The pad 20 comprises the mesh 12, zeolite (or other molecular sieve)particles 14 retained therein by the mesh 12, and a support 22 to whichpressure may be applied in the application of the pad 20 to a bleedingwound. The mesh 12, as above, has openings that are capable of retainingthe zeolite particles 14 therein while allowing the flow of bloodtherethrough.

The mesh 12 is stitched, glued, clamped, or otherwise mounted to thesupport 22. The support 22 comprises an undersurface 24 against whichthe zeolite particles 14 are held by the container 12 and a top surface26. The undersurface 24 is impermeable to the zeolite particles 14(migration of the particles into the support 22 is prevented) and isfurther resistant to the absorption of water or other fluids. The topsurface 26 is capable of having a pressure exerted thereon by a personapplying the pad 20 to a bleeding wound or by a weight supported on thetop surface 26. The entire support 22 is rigid or semi-rigid so as toallow the application of pressure while minimizing discomfort to thepatient.

To apply the pad 20 to a bleeding wound, the pad 20 is removed from itspackaging and placed on the bleeding wound. As with the pouch of theembodiment of FIGS. 1 and 2, the zeolite particles 14 are either indirect contact with the tissue of the wound or are in direct contactwith the blood. Pressure may be applied to the wound by pressing on thetop surface 26 with a hand or by placing a weight on the surface,thereby facilitating the contact between the zeolite particles 14 andthe wound and promoting the adsorption of the liquid phase of the blood.The pad 20 (with or without a weight) may also be held onto the woundusing a strapping device such as a belt, an elastic device,hook-and-loop material, combinations of the foregoing devices andmaterials, and the like.

Referring now to FIG. 4, another embodiment of the present invention isa bandage, shown at 50, which comprises zeolite particles 14 (or someother molecular sieve material) retained in a mesh 12 and mounted to aflexible substrate 52 that can be applied to a wound (for example, usinga pressure-sensitive adhesive to adhere the bandage 50 to the skin of awearer). The mesh 12 is stitched, glued, or otherwise mounted to asubstrate 52 to form the bandage 50.

The substrate 52 is a plastic or a cloth member that is conducive tobeing retained on the skin of an injured person or animal on orproximate a bleeding wound. An adhesive 54 is disposed on a surface ofthe substrate 52 that engages the skin of the injured person or animal.Particularly if the substrate 52 is a non-breathable plastic material,the substrate may include holes 56 to allow for the dissipation ofmoisture evaporating from the skin surface.

In the preparation of zeolite material for the devices of the presentinvention (i.e., formation of the material into particle form), aninitial level of hydration of the zeolite may be controlled by theapplication of heat to the zeolite material either before or after thematerial is formed into particles. However, it has also surprisinglybeen found that as the particle size of the zeolite is increased, themoisture content has less of a correlative effect on any exothermiaproduced as the result of mixing the particlized zeolite in blood. Assuch, formation of the zeolite material into the zeolite particles(shown at 14 in FIGS. 1-4), may be by extrusion, milling, casting, orthe like.

Although this invention has been shown and described with respect to thedetailed embodiments thereof, it will be understood by those of skill inthe art that various changes may be made and equivalents may besubstituted for elements thereof without departing from the scope of theinvention. In addition, modifications may be made to adapt a particularsituation or material to the teachings of the invention withoutdeparting from the essential scope thereof. Therefore, it is intendedthat the invention not be limited to the particular embodimentsdisclosed in the above detailed description, but that the invention willinclude all embodiments falling within the scope of the appended claims.

1. A device for promoting the clotting of blood comprising: a pouch thatis closed on all sides; and a molecular sieve in particle form which isretained in the pouch; wherein the pouch is composed of a meshcomprising a plurality of openings; wherein the molecular sieveparticles are configured to produce a diminished exothermic reactionupon contact with blood ; and wherein the molecular sieve particles are:sufficiently large to be retained by the mesh; and sufficiently small sothat at least a portion of the particles can protrude through at least aportion of the openings of the mesh to make direct contact with bloodoutside of the pouch.
 2. The device of claim 1, wherein configuring themolecular sieve particles to produce a diminished exothermic reactioncomprises controlling the initial level of hydration of the molecularsieve particles.
 3. The device of claim 1, wherein configuring themolecular sieve particles to produce a diminished exothermic reactioncomprises controlling the particle size of the molecular sieveparticles.
 4. The device of claim 1, wherein the molecular sievecomprises a zeolite.
 5. The device of claim 4, wherein the molecularsieve comprises an A-type zeolite.
 6. The device of claim 1, wherein themesh comprises at least one of polyester, cotton, wool, or silk.
 7. Thedevice of claim 1, wherein the particles have a diameter from about 2 mmto about 5 mm.
 8. The device of claim 1, further comprising at least oneof the following materials or agents mixed with, associated with orincorporated into the molecular sieve: a pharmaceutically-activecomposition, an analgesic, an antibiotic, or an anti-inflammatory agent.9. The device of claim 1, further comprising sterile packaging withinwhich the pouch is stored until the pouch is used.
 10. The device ofclaim 1, further comprising magnesium sulfate, sodium metaphosphate,calcium chloride, dextrin, a polysaccharide, silver ions or a compoundcontaining silver ions, combinations of the foregoing materials, orhydrates of the foregoing materials.
 11. The device of claim 1, whereinthe mesh is woven.
 12. A method of accelerating the clotting of blood ina bleeding wound comprising: providing an apparatus comprising:providing a pouch that is closed on all sides; providing a molecularsieve in particle form which is retained in the pouch; and wherein thepouch is composed of a mesh comprising a plurality of openings; whereinthe molecular sieve particles are configured to produce a diminishedexothermic reaction upon contact with blood; and wherein the molecularsieve particles are: sufficiently large to be retained by the mesh; andsufficiently small so that at least a portion of the particles canprotrude through at least a portion of the openings of the mesh to makedirect contact with blood outside of the pouch; applying the apparatusto the bleeding wound; and maintaining the apparatus at the bleedingwound at least until blood from the wound begins to clot.
 13. The methodof claim 12, wherein configuring the molecular sieve particles toproduce a diminished exothermic reaction comprises controlling theinitial level of hydration of the molecular sieve particles.
 14. Themethod of claim 12, wherein configuring the molecular sieve particles toproduce a diminished exothermic reaction comprises controlling theparticle size of the molecular sieve particles.
 15. The method of claim12, further comprising applying pressure to the apparatus while theapparatus is applied to the bleeding wound.
 16. The method of claim 12,wherein the molecular sieve comprises an A-type zeolite.
 17. The methodof claim 12, wherein the mesh comprises at least one of polyester,cotton, wool, or silk.
 18. The method of claim 16, further comprising atleast one of the following materials or agents mixed with, associatedwith or incorporated into the molecular sieve: a pharmaceutically-activecomposition, an analgesic, an antibiotic, or an anti-inflammatory agent.19. A method of manufacturing a hemostatic device, the methodcomprising: providing a pouch that is closed on all sides; and providinga molecular sieve in particle form which is retained in the pouch;wherein the pouch is composed of a mesh comprising a plurality ofopenings; wherein the molecular sieve particles are configured toproduce a diminished exothermic reaction upon contact with blood ; andwherein the molecular sieve particles are: sufficiently large to beretained by the mesh; and sufficiently small so that at least a portionof the particles can protrude through at least a portion of the openingsof the mesh to make direct contact with blood outside of the pouch. 20.The method of claim 19, wherein configuring the molecular sieveparticles to produce a diminished exothermic reaction comprisescontrolling the initial level of hydration of the molecular sieveparticles.
 21. The method of claim 19, wherein configuring the molecularsieve particles to produce a diminished exothermic reaction comprisescontrolling the particle size of the molecular sieve particles.